London, UK – 2026 – As Early Access Programmes continue to expand across Europe, pharmaceutical and biotech teams are facing a growing operational challenge: how to deliver timely patient access in a region where regulation remains highly fragmented, country-specific and difficult to scale.
Early Access Programmes (also referred to as Expanded Access, Managed Access, Compassionate Use or Pre-Approval Access Programmes) allow patients with serious, life-threatening or highly debilitating conditions to access investigational medicines outside of a clinical trial when no satisfactory authorised treatment exists.
While the European Medicines Agency can provide recommendations for compassionate use under Article 83 of Regulation (EC) No 726/2004, implementation remains the responsibility of individual Member States, meaning companies must navigate different national procedures, timelines, eligibility criteria and approval mechanisms across Europe.
This lack of harmonisation has made Europe one of the most operationally complex regions for Early Access Programme delivery. Unlike the United States’ single national FDA framework, Europe requires companies to manage multiple national systems, each with its own requirements for approvals, physician requests, supply logistics and payment models.
Recent comparative research into Early Access Programmes in France, Italy, Spain and the UK found that programmes vary significantly between countries, although common eligibility features include the absence of valid therapeutic alternatives and a presumed favourable risk-benefit profile.
France is often seen as one of Europe’s most structured early access environments, with pathways covering pre-marketing, post-marketing and pre-reimbursement access, while Italy uses multiple mechanisms including the 648 List, the 5% Fund and Compassionate Use routes.
For companies attempting to launch programmes across multiple European markets, this creates a critical strategic question: how can global teams design programmes that remain compliant, patient-focused and scalable while adapting to national differences?
According to PwC, managed access programmes are increasingly being recognised as an essential part of the broader access continuum, particularly as organisations seek to address high unmet medical need while preparing for market entry and engaging healthcare systems earlier in the product lifecycle.
The challenge is no longer simply whether to open an Early Access Programme. It is how to determine where, when, under which pathway, with what evidence strategy, and with which operational infrastructure.
That is why the 5th Operationalise: Early Access Programmes Summit Europe, taking place in London in October 2026, will bring together 140+ Early Access, Medical Affairs, Patient Access, Regulatory, Clinical Operations and Supply leaders to benchmark how programmes are being planned, launched and scaled across European and global markets.
The 2026 summit is designed to help teams address the practical realities of programme execution, including European pathways, paid early access models, post-trial access, real-world data generation, clinical supply, rare disease programme delivery and global operational strategy.
As access teams move from reactive compassionate use models to proactive global access planning, one message is clear: Europe’s fragmented landscape demands earlier strategic preparation, stronger cross-functional alignment and practical peer benchmarking.
For organisations responsible for delivering investigational medicines to patients before approval, the ability to understand national pathway differences and operationalise them effectively is becoming a defining capability.
Download the full event guide to explore how Europe’s only dedicated Early Access Programmes forum will help teams navigate regulatory complexity and deliver earlier patient access in 2026 and beyond.
Sources
- PwC Belgium. Navigating the Complexities of Early Managed Access Programmes. PwC, 2025.
- Pharmablue. Ultimate Guide for European Early & Expanded Access Programs. Pharmablue, 6 March 2025.
- Tarantola, A., Otto, M.H., Armeni, P., Costa, F., Malandrini, F. & Jommi, C. Early Access Programs for Medicines: Comparative Analysis Among France, Italy, Spain, and UK and Focus on the Italian Case. Journal of Pharmaceutical Policy and Practice, 2023.
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